News Archive

EMA/HMA - Big Data Workplan 2023-2025

2nd August 2023

HMA/EMA joint Big Data Steering Group

Read More+

FDA - Roundup: 1st August 2023

2nd August 2023

An at-a-glance summary of news from around the FDA.

Read More+

MHRA - Annual conflict of interest compliance report for 2022

2nd August 2023

Annual conflict of interest compliance report for 2022 added to the MHRA website.

Read More+

MHRA - CE marking recognition for medical devices and in vitro diagnostics

2nd August 2023

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.

Read More+

WHO - Public consultation on WHO guidance for best practices for clinical trials

27th July 2023

In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. Please see action 2 under section “Requests the Director-General” at the end of WHA 75.8 resolution here. WHO is launching a public consultation on draft guidance developed in line with this request.

Read More+

EMA - CTIS Newsletter July 2023

20th July 2023

EMA is pleased to share that the 15th issue of the ‘Clinical Trials Highlights’ newsletter has been published. The newsletter provides insights on clinical trials topics, including on the ACT EU initiative and CTIS.

Read More+

EMA - Reflection paper on the use of artificial intelligence in the lifecycle of medicines

20th July 2023

EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.

Read More+

EMA - public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data

20th July 2023

The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines”, co-authored by EMA, US FDA and Health Canada. This Reflection Paper builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data (RWD) and real-world evidence (RWE). It constitutes the first step towards international harmonisation of the following focus areas: Convergence on terminology for RWD and RWE Format for protocols and reports of study results based on RWD submitted to regulatory agencies throughout the lifecycle of medicines Registration of study protocols and reports EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment. Your input is crucial to help shape the future ICH guidelines that will address the complexity of use and impact of RWD/RWE in medicines regulation. Comments should be provided using this template and sent to ich@ema.europa.eu by 30 September 2023. For more details on this topic, please click here.

Read More+

EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023

19th July 2023

11-13 July 2023

Read More+

EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023

19th July 2023

3 - 6 July 2023

Read More+